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PEST Analysis

As part of our gold medal requirements for human practices, we have decided to use an analytical framework largely used within social sciences, the PEST analysis. PEST (political, economic, social and technological) describes a framework of macro-environmental factors used in the environmental scanning component of social sciences. We have decided to adapt it to our iGEM project in order to examine in a more structured way the macro-environmental factors that will have an impact on our project. This analysis is used to assess these four external factors in relation to our situation. Even though PEST is usually used for business management and organisational purposes, we recognised that such an approach would have represented a useful tool for integration of social science into our synthetic biology project. As human practices tend to emphasise the importance that factors outside of the laboratory affect our work, and how our work affects the world outside, a PEST analysis has helped us determine the weight that each one of those factors will have on the success of our project.

Political

In terms of political factors affecting our project, we have incorporated public policy as well as legal considerations in order to have a comprehensive political framework. This year we have considered legislation regarding both the use of GMO biosensors within the European Union, as well as regulations on food hygiene standards and general food safety law. In addition, we have devolved particular interest to recent political changes that might affect our project; specifically, we have considered potential implications that Brexit will have on future national legislation. In terms of GMO legislation, we have found out that the central issue is the use of live genetically modified organisms outside a contained and properly registered laboratory. This is covered in the EU by 2009/41/EC for contained use and 2001/18/EC for deliberate release into the environment, or in the UK, the Genetically Modified Organisms (Contained Use) Regulations 2014. In terms of food safety law and food hygiene legislation, we have considered several policies that the UK has been adopting in order to ensure that farming, food safety management procedures, and food hygiene regulations are being kept at high standards. Some of these policies include the Regulation (EC) 178/2002, which set out the general principles and requirements of food law in the EU; and EU Regulation 882/2004 on official controls for feed and food law (and animal health and animal welfare) sets out the approach that competent authorities of member states must adopt for official controls. Since most of the legislation we have considered is EU-derived, we believed it would be useful to analyse the potential impacts that an upcoming exit of the UK from the EU would cause to the future of such policies. For this reason, we have dedicated particular attention to the recent political turmoil that has been characterised by uncertainty on the future of national legislation. A detailed policy brief can be found here.

Economic

In terms of economic impacts of our project, our main priority is to create a biosensor that will be economically advantageous compared to current costs that laboratories have to face when testing chicken for campylobacter. When researching current data on economic costs associated with this, we asked Scotland's Rural College about current procedures used for testing chicken for campylobacter. At present the procedure includes swabbing the birds, sending the swab to the lab and get the results up to a week later. We were told that an instant result would have been most helpful. In order to establish the economic costs associated with such a procedure, we analysed figures that determined the current costs, technologists’ time, and time to a positive and negative result using conventional culture methods. The figures were provided by the Department of Pathology, University of Texas Southwestern Medical Center^[1], that recorded the costs per stool culture for media and reagents. According to the statistics, average costs for media and reagents for cultures were as follows: No potential pathogens, $5.74 (£4.28) (n=74); negative cultures with additional workup, $7.27 (£5.43) (n=127); and positive cultures, $9.33 (£6.96) (n=5). Shigella sonnei, Campylobacter species and Salmonella species were the bacterial pathogens that were recovered in the 5 positive cultures. To evaluate the technologists’ time, 5 different technologists recorded the time that they spent on stool workups. The average technologist time required to complete a single final culture was approximately 8 minutes (range of 1-15 minutes). Using an average cost of $27 (£20.16) per hour for technologists’ labour and benefits and 8 minutes of time per culture, the labour cost per culture was $3.60 (£2.69). Including media, reagents and labour, the average cost to detect a single positive culture was $427 (£318.76). While negative cultures with no potential pathogens were reported at 48 hours, positive cultures required 72 to 96 hours to finalise. Our aim is to reduce the economic impact that comes with swabbing and using laboratory facilities, by providing a more affordable alternative that saves users both time and money. On a macro-scale, being the UK economy enormously affected by campylobacter related infections, our biosensor will serve as a tool to benefit macro economic issues.

Social

Our targeted stakeholders can be divided into three categories; farms, industrial kitchens, and private customers at home. As a consequence, the biosensor will be used to detect campylobacter at different stages of the process, even though it will serve the same purpose. The social factor was particularly important to us as human health is the main reason behind our research project. We wanted to find a quick and easy solution for an issue that negatively affects it, since campylobacter related infections represent an enormous issue for human health in the UK as well as in the rest of the world, but they are so easily preventable that the amount of infections could ideally drop to zero with education and prevention.

Technological

The aim of our project was to make a functioning genetically engineered biosensor. The device consists of 3 elements:

• Swab attached to a syringe containing 1% acetic acid
• Processing plate for preparing the sample for detection
• Heating Element using a separate electronic circuit

A swab of the area for testing is taken, and then inserted into the input section of the processing plate. The syringe is the pushed slowly to detach the sample and pass it through the device. To prepare the sample, it is taken through a series of stages which will release the sugar xylulose from the capsule of any campylobacter bacteria present. These being:

• Heating the acid and sample to 100 Degrees Celsius (which detaches xylulose)
• Neutralising the acid using a Tris-Acetate buffer (making the solution innocuous to the E. coli)
• Testing the pH using litmus paper
• Mixing with glucose (ensuring the E. coli does not metabolise the xylulose)

After the stages mentioned above, the sample is ready to be delivered to the detection chamber. Here, a strip of filter paper that had been pre-prepared with a hydrogel coating that contained our genetically modified E. coli cells is inserted into the chamber which allows the liquid sample to diffuse into the cells. The detection chamber, along with the rest of the device, is transparent, allowing the user to observe any colour changes should xylulose be present in the sample.

Acting on Campylobacter Together Campaign (FSA)

As part of our integrated human practices, we decided to reach out to regulators in order to have a better idea of the future of the legislation regulating hygiene standards in the UK industry. We wanted to know what exactly are the protocols to follow in order to make sure campylobacter levels are minimised and the criteria that regulate hygiene standards. These regulators in the UK are represented by the Food Standards Agency. We were lucky enough to receive a response from the FSA that accepted to speak to us and answer our questions. In particular, the FSA has been promoting in recent years a campaign that aims to educate the public on what campylobacter is and how to prevent food poisoning, called “Acting on Campylobacter Together”. From their figures, an extensive portion of the public was not aware of what campylobacter is, or how to minimise the risk of foodborne related infections; however, almost 30% of people reported concern about food poisoning (FSA, 2017). In the following section, we have reported our conversation between the FSA from the Foodborne Disease Control policy area, and our iGEM team. In addition, we have provided some important selected figures that the FSA has kindly shared with us.

What is the protocol in the UK if there is an outbreak of a poultry bacterium?

Our first question regarded any potential protocol that the industry needs to follow if there is an outbreak of a poultry bacterium. We found out that there isn’t any protocol at the present time that regulates this. At the current stage there are not any laws governing the levels of Campylobacter in the UK. There is a process for food hygiene criteria but there is a lack of food safety criteria. Slaughterhouses must assess their hygiene standards and make adjustments accordingly; however, they can choose not to disclose their hygiene scores. According to our sources, there will be an initial EU legislation enforced in January 2018 regulating better hygiene criteria in the food industry, and this legislation will be implemented despite the Brexit negotiations.

What is the legislation regulating Campylobacter levels in food outlets?

We also asked the FSA whether there is legislation for food outlets in terms of Campylobacter levels; once again there is a gap in legislation regarding Campylobacter. Hygiene standards exist of course and outlets have a responsibility to produce safe food. There is a target of 103 colonies per gram, in no more than 10% of products. The EU has food hygiene laws and the overarching message is that food outlets should produce safe food; however, the way this is regulated is still extremely unstable. The key idea is that it is voluntary in England and Scotland to post hygiene scores at restaurants. Accordingly, there are two types of restaurants:

• restaurants that voluntarily disclose their hygiene scores on their doors and
• restaurants that do not disclose scores on their doors.

However, the FSA’s dataset does not contain such a voluntary disclosure status; we have also found that no academic study has investigated the economic incentives behind this voluntary (non-)disclosure; therefore, there is also a gap in academic literature.

What is the position of the UK on chlorine-washed chicken?

We asked regulators about their position of chlorine washed chicken. We found this discussion extremely interesting as here seems to be profound disagreement between the EU and US position on the topic. According to our sources at the FSA, the UK’s position is that they do not perceive it as a problem or cause of trouble; the EU however does not allow chlorine washes of poultry products. Whether or not the UK laws will change post Brexit, that is an issue that will be decided during the trade negotiations. The FSA has promoted focus groups that appear to be reluctant signing on to this decision, as does industry for fear of lost sales. In addition, the British Poultry Council has also come out against chlorine washed chicken. To find out more about the debate on chlorine-washed chicken please have a look at our page highlighting the discussion.

What are the practices used to reduce Campylobacter levels?

We analysed figures that stated that last year 65% of chicken carcasses in the UK were contaminated with Campylobacter. This year figures were sitting at around 50%. Therefore, we enquired about the remaining 35-50% which weren’t contaminated, and asked for further clarification on the practices used by the industry. The FSA has been promoting a national campaign that emphasises the importance of raising awareness on the dangers caused by Campylobacter; the campaign has worked with industry to help introduce interventions to help reduce the bacterial load on chicken carcasses in the UK. In the slaughterhouse there are interventions they have encouraged, and they mainly break down into hot and cold interventions. In the hot intervention, the carcasses are scalded at 80oC for a few seconds to help reduce the bacterial load on the carcass. In the cold intervention, the carcasses are sprayed with liquid nitrogen or super cooled air to help reduce bacterial load. In farms it is becoming more common to segregate certain sheds to help reduce the potential for cross contamination. It is useful to note that these interventions are not always 100% effective in every factory. The practice of the techniques can affect the outcome.

We asked regulators whether they had seen an increase in the utilisation of hot and cold interventions, used in order to prevent Campylobacter from developing. From our figures, it seems that 85% of the industry producers of chicken in the UK have taken up these interventions and the FSA is hoping to get the rest to do that as well, therefore they hope to see the continued use of such interventions in order to further reduce the levels of campylobacter.

Figures and statistics

As reported by the FSA, consumers do not perceive food poisoning to be a high risk in relation to home-prepared food; and if they do encounter it, they expect it to have limited consequences. They are confident they can manage the risk from food poisoning when preparing the food themselves. Consumers voiced greater concern about

• the long term impacts of poor diet and the use of chemicals and additive in food, and
• what happens outside the home, both in terms of restaurant hygiene and the safety of food production processes.

Consumers are generally content with the current balance of responsibility between consumers/Government and industry. Overall, they are positive about the measures that Government takes to protect them from the risk of food harm. There is however a belief that the Government should educate consumers so they know what the recommended behaviours are – even if they may not act on this information. They also maintained that Government has a responsibility to monitor industry to ensure that standards are maintained and/or improved. There was limited support for industry interventions to reduce food poisoning where this impacted on cost or choice for consumers. The figures provided by the FSA suggest that 29% of people reported concern about food poisoning. The top food safety issues of concern were: food hygiene when eating out (36%), chemicals from the environment such as lead in food (30%), food poisoning (29%), and food additives (29%).

In conclusion, Activity related to food preparation and storage is highly habitual and ingrained and therefore people do not tend to make logical, reasoned judgements for action but rely on their ‘instinct’ about the right thing to do. It may be that behaviour will only change after a slow road to social norming via saturation methods for harder to sell messages. Directly challenging strongly held beliefs and habitual practices around food in the home undermines the link between ‘home’, safety and personal efficacy in a way that people often find unacceptable. However, education from the FSA and government with campaigns such as “Acting on Campylobacter Together” has been proved to be helpful to as it has successfully alerted people to hidden dangers in their homes without undermining their sense of personal efficacy or more general safety.

References